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Regulatory Affairs Director
2 months ago
HARPS Global Pte Ltd is seeking a seasoned Regulatory Affairs professional to lead our global team and drive regulatory compliance across our worldwide offices.
This role will require managing a global team and approximately 25% travel is expected.
Key Responsibilities:- Develop and implement global policies for worldwide offices, ensuring consistency and compliance with regulatory requirements.
- Stay abreast of evolving regulatory trends and best practices, providing strategic direction and insight on local and regional regulatory issues.
- Identify and address regulatory risks and opportunities to facilitate business growth, collaborating with global counterparts to ensure regulatory compliance.
- Serve as the Subject Matter Expert, presenting regulatory reports, summaries, and updates to the senior management team.
- Collaborate with cross-functional teams to ensure all products comply with safety and regulatory requirements, consistent with commercial requirements.
- Represent HARPS Global Pte Ltd as the regulatory spokesperson on regulatory issues and developing legislation, aligning with business directions.
- Participate in internal and external audits to ensure regulatory compliance, maintaining and updating regulatory authorizations, licenses, and certifications.
- Supervise, lead, and manage a team of regulatory affairs and quality assurance experts to support business growth.
- Bachelor's degree or equivalent.
- Certification in regulatory affairs is a plus.
- Minimum 10 years of experience in regulatory affairs, with deep industry knowledge relevant to the company's business environment.
- Track record of business partnership to help build growth.
- Strong understanding of global legal and regulatory requirements and guidelines.
- Excellent interpersonal skills, with the ability to engage effectively with diverse stakeholders.
- Strategic mindset, analytical thinking, and sound judgment in complex decision-making situations.